MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PIN; IMPLANT

Catalog Number UNK_SEL

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report.Additional devices listed in this report: (b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

It was reported by the doctor, that the patient claims that the pin of fixateur hoffmann3 with carbon rod got hot during mrt.Mrt aborted; complete use from loaner set in product details added to report composition of fixateur.

Manufacturer Narrative

As per literature, the heating of an external fixation frame is highly dependents on mri settings and on the structure of each frame.However, even though requested no information was provided about the mri scanner settings during this case.A picture of the built frame was provided: this frame is a complex structure with a large amount of components (including 6 pins + 21 reported parts) and includes several opened and closed loops.The frame structure is not similar to any tested frame from the operative technique.Radiologist and mr-scientists should have been consulted about this frame before performing the mri scanner.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a deviation from operative technique recommendations.Device history files of each reported device from this frame, were reviewed: all reported devices are conforming to specifications.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.If any further information is provided, the investigation report will be updated.

Event Description

It was reported by the doctor, that the patient claims that the pin of fixateur hoffmann3 with carbon rod got hot during mrt.Mrt aborted; complete use from loaner set in product details added to report composition of fixateur.

Manufacturer Narrative

A picture of the built frame was provided: this frame is a complex structure with a large amount of components (including 6 pins + 24 reported parts) and includes several opened and closed loops.

Event Description

It was reported by the doctor, that the patient claims that the pin of fixateur hoffmann3 with carbon rod got hot during mrt.Mrt aborted; complete use from loaner set in product details added to report composition of fixateur.

• Brand Name: UNKNOWN PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5554189
• MDR Text Key: 42763623
• Report Number: 0008031020-2016-00165
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 107